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Clinical Trials/NCT01109446
NCT01109446
Completed
Not Applicable

Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution

University of Aarhus1 site in 1 country60 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Platelet Rich Plasma
Conditions
Lateral Epicondylitis
Sponsor
University of Aarhus
Enrollment
60
Locations
1
Primary Endpoint
Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution.

All injections are guided by ultrasonography.

Detailed Description

Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Duration of tennis elbow \> 6 months
  • Doppler activity on ultrasonography
  • Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger.

Exclusion Criteria

  • Inflammatory disease.
  • Fibromyalgia.
  • Pain in hand or shoulder/neck in the same arm as being treated.
  • Anticoagulation treatment.
  • Wounds around the elbow.
  • Treatment with steroids within the last 3 months.

Arms & Interventions

Platelet Rich Plasma

Intervention: Platelet Rich Plasma

Isotonoic Saline Solution

Intervention: Isotonic Saline Solutions

Steroid (Triamcinolonacetonid)

Intervention: Triamcinolonacetonid

Outcomes

Primary Outcomes

Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.

Time Frame: first day, 1 months, 3 months, 6 months, 12 months.

We use the PRTEE questionaire, which is validated for tennis elbow.

Secondary Outcomes

  • Functional Disability(First day, 1 month, 3 months, 6 months, 12 months)
  • Ultrasonographic changes(first day, 1 months, 3 months, 6 months, 12 months)
  • Adverse events(through out the entire 12 months)
  • Pain induced by the treatment(1 months after treatment)

Study Sites (1)

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